Birth-control Pill Mishap Leads to Lawsuits, Baby Boom

In the aftermath of a pharmaceutical packaging error, patients are giving birth to surprise babies, and some are litigating.

Shanta Russell had been taking her birth-control pills faithfully for more than a dozen years without a hitch. So when pregnancy tests kept turning up positive in June 2011, she was stunned.

Shock turned to anger three months later when the single Kansas City woman received a recall notice in the mail warning that the pills she had taken may have been placed in the wrong order in their blister packs. The mistake could render the pills ineffective.

That recall in September 2011 by Qualitest Pharmaceuticals, the manufacturer of the pills Russell took, was followed closely last year by unrelated but eerily similar recalls of birth control pills with faulty packaging from three other manufacturers: Pfizer in January, Glenmark Generics in February and Sandoz in June.

The recalls involved millions of blister packs of pills distributed to warehouses and pharmacies. Consumer health advocates say the problems were the inevitable consequence of inadequate federal monitoring of drug manufacturing plants.

How many women became pregnant while taking the pills is unknown, but could easily number in the hundreds.

Russell, 33, now is the mother of a 1-year-old child. She is suing Qualitest, its parent corporation, and the company that packaged the pills. Her lawsuit, filed Feb. 6 in Jackson County Circuit Court, seeks compensation for her health care costs, for the cost of raising her child and for the emotional pain she's been through.

"I was devastated," Russell said. "I questioned myself. After all these years, how could this happen? Then I received a letter in the mail. Of course I was angry. There was nothing I did that was a mistake."

Kevin Wiggins, spokesman for Endo Pharmaceuticals, Qualitest's parent company, said it was company policy not to comment on pending litigation.

Russell describes herself as a workaholic with a passion for travel. Before her daughter was born, she held down two jobs. Her free time was spent on trips to hot spots like Jamaica, Miami and Las Vegas. She planned to go back to school to train for a job in health care.

Motherhood was just a distant possibility. "Later on in life, once upon a time, I was planning to be a mother," she said.

Russell took a home pregnancy test after missing a period. Dumbfounded by the result, she took the test two more times. "I couldn't get over the fact it was happening." But a visit to the doctor confirmed it.

Russell considered having an abortion. "It crossed my mind. But I thought: I'm older now. I don't have too much time to wait to have children. It's here. And I thought about it again, how an abortion would affect me. I couldn't deal with myself."

Lawsuits by other women who became pregnant while taking Qualitest pills have been filed across the country, including California, Texas and Tennessee.

Shortly after Qualitest's recall was announced, a proposed class-action suit was filed in Georgia on behalf of women who took the pills. Lead attorney Keith Bodoh declined to discuss the case with The Star because he was in discussion with Qualitest and the other defendants.

But in an interview last year in The Atlantic's online edition, Bodoh said he had been contacted by more than 200 women, virtually all of them claiming to be pregnant because of Qualitest's defective packaging. His clients included women who had to drop out of nursing or law school, a woman in the military who gave up her baby for adoption because she was about to be deployed and a woman who was pregnant with twins.

How the pills work -- or don't

Most of the pills included in the recalls were older generation contraceptives that are very popular because they come as low-cost generic brands, said Madhuri Reddy, acting director of general obstetrics and gynecology at the University of Kansas Hospital.

The pills contain a combination of two hormones, progestin and estrogen, that block eggs from being released. The blister packs are supposed to provide pills containing the hormones -- in three rows of seven -- for the first 21 days of the woman's monthly cycle.

The seven pills in the final row are placebos, dummy pills placed in the pack for women to take to keep them on a daily routine. During that week, the woman has a period.

"That was considered the norm, to have a period every month, so they designed the pills that way," Reddy said.

The recalled Sandoz Introvale pills work in a similar fashion, but come in blister packs of 84 active pills and seven placebos, allowing women to have periods every three months.

Theoretically, contraceptive pills can prevent more than 99 percent of pregnancies. But that's only if women remember to keep to their daily regimen and don't have other health issues, Reddy said.

"Pills are usually as reliable as the person taking them," she said.

What caused the recalls were packaging errors that placed placebo pills at a point in a woman's cycle where pills containing hormones should have been.

"At the wrong time is the key," Reddy said. "Even a couple of days of placebos would put you at some risk of pregnancy."

In the blister packs involved in the recalls, the active pills and placebos were different colors. In some cases, the drug companies learned about the mix-ups from a vigilant pharmacist or a woman taking the pills.

Limits for the FDA

To Amy Allina, policy director of the National Women's Health Network, a Washington-based advocacy group, the recalls are a sign that the federal Food and Drug Administration doesn't have the resources to inspect manufacturing plants often enough.

"If you don't have regular inspections, they're inevitably going to have quality problems," she said. "We've set up a system that is way too porous."

The FDA had been inspecting domestic plants on average every two and a half years, even though inspections were mandated every two years. According to a 2010 Government Accountability Office report, it would take the FDA nine years to inspect all foreign suppliers at the rate it was going. Factories in other countries produce most of the materials going into U.S. drugs. Birth-control pills involved in three of the four recalls came from foreign manufacturers.

Legislation approved last year boosts fees on manufacturers to provide the FDA with more money for inspections. The FDA also will be required to inspect foreign plants at the same rate as domestic.

"Our position is they should be looking at them every year, certainly domestically," Allina said.

But even as it inspects factories, the FDA relies on drug makers to initiate recalls."The FDA really doesn't have legal authority to mandate (drug) recalls, believe it or not," said Michael Carome, a physician and deputy director of Public Citizen's Health Research Group. "All FDA can do is twist their arm."

Up to the courts

Whatever settlement is reached in the lawsuit against Qualitest in Georgia may set a benchmark for payments offered to other women who have sued, said Russell's lawyer, Chuck Chionuma of Kansas City.

But that may be less than what Russell is asking for, legal experts said.

"The courts are relatively hostile to these actions," said I. Glenn Cohen, co-director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School.

Cohen said most states, including Kansas and Missouri, allow what lawyers call wrongful pregnancy or conception cases. Usually, they've involved failed vasectomies or tubal ligations; only rarely have contraceptives been the cause for action.

But generally, courts have limited parents to claims of emotional distress, lost wages and the medical costs of the pregnancy. They haven't been willing to allow parents to collect damages to cover the costs of raising and educating their unexpected child.

Judges have used a variety of rationales for ruling this way, among them variations on the "blessing doctrine," Cohen said. "Producing a healthy life is a blessing, therefore there's no damage to you."

Another harder-edged reason that courts have given: Rather than raise the child, the mother could have chosen abortion or adoption.

When the Missouri Supreme Court ruled in 1992 against permitting claims for child-rearing and education expenses in wrongful pregnancy cases, it said cost calculations would be speculative. And whether those costs would be outweighed by the emotional benefits conferred by the child would be impossible to gauge.

"The child may turn out to be loving, obedient and attentive, or hostile, unruly and callous. The child may grow up to be president of the United States, or to be an infamous criminal," the court said.

"Your plaintiff (Russell) is going to have a hard time" seeking child-rearing costs, Cohen said. "I don't begrudge her lawyer. For her sake, I wish him a good day in court."

Chionuma said he was prepared.

"We're being very careful in structuring our legal argument," Chionuma said. "In other aspects of tort law, the wrongdoers aren't given any credit for benefits to the victim. We're very hopeful, yes."

For Russell, parenthood has brought the expenses of baby clothes, day care, diapers and doctor appointments. She no longer has time for two jobs. Her travel and education plans are on hold.

"When you have a kid you have to rearrange your life. You have to cut back on things."

But Russell lit up as she spoke of her baby girl.

"She has an amazing personality. She's the happiest child," Russell said. "She's the most precious thing that ever happened. I can't live without her."